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IV efgartigimod
Efgartigimod is an IgG Fc receptor inhibitor that reduces circulating immunoglobulin G (IgG) antibodies by blocking their recycling through the neonatal Fc receptor (FcRn).
Efgartigimod is an IgG Fc receptor inhibitor that reduces circulating immunoglobulin G (IgG) antibodies by blocking their recycling through the neonatal Fc receptor (FcRn). Used for Generalized myasthenia gravis (gMG).
At a glance
| Generic name | IV efgartigimod |
|---|---|
| Also known as | vyvgart |
| Sponsor | Rambam Health Care Campus |
| Drug class | FcRn inhibitor |
| Target | Neonatal Fc receptor (FcRn) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Efgartigimod binds to the neonatal Fc receptor (FcRn) on endothelial cells, preventing the recycling and prolonging the half-life of IgG antibodies. This leads to increased catabolism and reduced serum levels of pathogenic IgG antibodies. In autoimmune conditions mediated by IgG, lowering circulating IgG levels reduces disease activity.
Approved indications
- Generalized myasthenia gravis (gMG)
Common side effects
- Infection (including upper respiratory tract infection)
- Headache
- Fatigue
Key clinical trials
- Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis (PHASE3)
- A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia (PHASE3)
- A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP) (PHASE2, PHASE3)
- ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
- Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis (PHASE2, PHASE3)
- A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
- ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod (PHASE2)
- Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IV efgartigimod CI brief — competitive landscape report
- IV efgartigimod updates RSS · CI watch RSS
- Rambam Health Care Campus portfolio CI